WAYNE, PA — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, has announced the first patient enrollment in the ACCESS-MANTA™ Registry. This international, multicenter, prospective, observational, single-arm clinical registry is designed to examine the on-label use of the MANTA™ Vascular Closure Device (VCD) in standard care transcatheter aortic valve replacement (TAVR) procedures.
The registry aims to enroll a minimum of 250 patients across 15 leading TAVR institutions in the US and Canada. It will evaluate both appropriate patient selection and proper vascular access.
The primary objectives of the ACCESS-MANTA™ Registry are to assess safety, defined by large bore access site-related Valve Academic Research Consortium-3 (VARC-3) major and minor vascular complications within 30 days of the TAVR procedure, and effectiveness, as indicated by time to hemostasis. The study will also evaluate technical success, treatment success, ambulation success, discharge readiness, and procedure time.
“Large bore access site complications can lead to increased costs and prolonged length-of-stay,” said Christopher Buller, MD, Teleflex Interventional Medical Director. “Percutaneous cardiac and peripheral procedures, like TAVR, performed through large bore arteriotomies, need dedicated closure technology that is safe, effective, and procedurally efficient.”
Teleflex believes that the MANTA™ Device demonstrated these attributes in the pivotal SAFE MANTA IDE Clinical Trial. However, TAVR practice has evolved to embrace routine access site imaging, awake procedures, smaller delivery systems and sheaths, lower-risk patients, and significantly higher per-operator experience. The ACCESS-MANTA™ Registry will help understand the extent to which these changes, along with a dedicated device that is optimally deployed, may improve large bore outcomes.
George Dangas, MD, PhD, Professor of Medicine (Cardiology), and Surgery, and the Director of Cardiovascular Innovation at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, is the study chair. Sahil Khera, MD, Interventional Director of the Structural Heart Program at The Mount Sinai Hospital, and Danny Dvir, MD, Director of Interventional Cardiology at Shaare Zedek Hospital Center, Jerusalem, are the principal investigators of the study.
“We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator. “We look forward to this contribution to the advancement of large bore access and closure.”
The ACCESS-MANTA™ Registry represents a significant step forward in the ongoing efforts to optimize patient outcomes in TAVR procedures. The findings from this study will provide valuable insights into the contemporary use of the MANTA™ VCD and its potential to improve patient care.
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